Wednesday, June 14, 2017

Gilead (GILD) Submits NDA for HIV Combination Therapy Regimen

Gilead Sciences, Inc.GILD announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF).

The regimen is novel experimental integrase strand transfer inhibitor which is being evaluated for the treatment of HIV-1 infection in adults.

The data from the study showed that BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in phase III trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

The NDA is supported by encouraging data four phase III studies in which the regimen met its primary objective of non-inferiority. We note that three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared with regimens containing GlaxoSmithKline’s GSK Tivicay (dolutegravir) (50mg) (DTG) among treatment-naïve patients and virologically suppressed patients switching from an existing antiretroviral regimen.

The fourth study is being conducted among virologically suppressed patients and compares switching to BIC/FTC/TAF versus on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Gilead plans to submit a marketing authorization application for the regimen in the European Union in the third quarter of 2017.

Gilead is a dominant player in the HIV market, with an impressive portfolio. The newly launched TAF-based products Genvoya, Odefsey and Descovy are performing well, with strong adoption in both the U.S. and EU. Genvoya has already become the most-prescribed regimen for both treatment-naïve and switch patients since its launch in Nov 2015.

Also, Genvoya has been listed as a preferred regimen in several HIV treatment guidelines. The TAF-based regimens now represent 42% of total Gilead HIV prescription volume following the launch of Genvoya, Odefsey and Descovy in 2016. Genvoya is now the company’s best-selling HIV product, surpassing both Truvada and Atripla since fourth-quarter 2016.

The uptake in HIV franchise should help the company combat the persistent decline in HCV franchise due to competitive pressure. Competition as well as pricing pressure has intensified further with the launch of Merck’s MRK Zepatier.

However, Gilead’s HIV products are not only facing generic threats but also steep competition primarily from Tivicay and Triumeq. Meanwhile, Gilead will lose exclusivity for Viread in 2017 in some countries outside the U.S. which should impact sales.

Shares of Gilead underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last year with the stock losing 21.7% during this period, compared with the industry’s decline of 4.9%.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in each of the trailing four quarters, with an average beat of 233.69%.

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